Multi-method and multi-apparatus for treating obesity

ABSTRACT

A multi-method and multi-apparatus for treating obesity. The multi-method includes a method for estimating a volume of an intragastric balloon appropriate for an individual patient, a method for using an enterocutaneous fistula to inspect an intragastric balloon without sedation and endoscopic complications associated with an upper endoscopy, and a method for decreasing ability of the stomach of an individual patient to distend or expand after a meal increasing satiety and helping the individual patient to comply with a weight loss diet. The multi-apparatus includes an intragastric balloon for inflating without installation of a pressurized gas or liquid, an intragastric balloon for minimizing trauma of the intragastric balloon on the gastric mucosa, and an intragastric balloon for administering therapeutic medications.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/069,681, filed Feb. 12, 2008, entitled “Multi-method andmulti-apparatus for treating obesity,” and claims priority to U.S.provisional patent application Ser. No. 60/901,044, filed on Feb. 13,2007, entitled “Methods for Treatment of Obesity,” the disclosures ofwhich are incorporated by reference herein in their entireties as iffully set forth herein.

BACKGROUND

1. Field of the Invention

The embodiments of the present invention relate to a treatment forobesity, and more particularly, the embodiments of the present inventionrelate to a multi-method and multi-apparatus for treating obesity.

2. Description of the Related Art

In the published medical literature, there are a significant number ofpatients who experience adverse gastrointestinal complaints in theperiod immediately after the deployment of an intragastric balloon. Inthis experience, all patients are treated with one specific model andsize of balloon.

Thus, there exists a need for an intragastric balloon wherein both thegeometry or shape of the balloon, as well as the volume of the balloon,are components that can be manipulated to enhance the therapeutic effectand to minimize complications.

In the published medical literature, intragastric balloons are placed ina deflated form and than inflated once in the stomach. The only materialholding the balloons in their active shape is either air, liquid, orboth. It is possible for these substances to leak out of the ballooncausing the balloon to deflate and fail.

Thus, there exists a need for an intragastric balloons including askeleton of metal struts that strengthen the balloon structure andprevent premature balloon failure, which could lead to a loss oftherapeutic effect in obesity and can also lead to small bowelobstruction or gastric outlet obstruction.

In the published medical literature, intragastric balloons have beenassociated with the complication of irritation of the lining of thestomach (gastritis) and gastric ulceration. Considering the example ofthe intragastric balloon already patented by the instant inventors asU.S. Pat. No. 4,694,827, this complication was contemplated and asolution offered by using an intragastric balloon having protrusions andchannels.

Non-compliance with therapeutic medications is a well known clinicalproblem interfering with good patient outcomes. Many different solutionshave been attempted to deal with this problem, and to date, none havebeen completely satisfactory.

In the medical literature, damage to the lining of the stomach has beena major complication of intragastric balloon therapy. In many cases,severe damage, such as ulceration, may require removal of the balloon.Alternatively, there are many cases of patients with symptoms that mightbe related to the intragastric balloon, but might also be related tointercurrent viral illnesses, food poisoning, or milder complications ofballoon therapy, not necessitating balloon extraction. In currentpractice, patients would undergo an upper endoscopy to assess thesituation.

There are a multitude of methods purported to treat obesity in humans.Among the most effective of these methods are surgical techniques thatalter the volume of the stomach available to receive food from the mouthand esophagus. The most popular of these surgical techniques is oftenreferred to as a (Roux en Y) gastric bypass procedure. The gastricbypass is thought to work by limiting the amount of food that can beingested at one time, although it may also alter gastrointestinalhormones and decrease the appetite.

Numerous innovations for inflatable medical devices have been providedin the prior art, which will be described below in chronological orderto show advancement in the art, and which is incorporated herein byreference thereto. Even though these innovations may be suitable for thespecific individual purposes to which they address, however, they differfrom the present invention in that they do not teach a multi-method andmulti-apparatus for treating obesity.

-   (1) U.S. Pat. No. 766,336 to Farrington.

U.S. Pat. No. 766,336 issued to Farrington on Aug. 2, 1904 teaches adevice including a fluid-supply tube having a plurality of parallelslots and springs arranged within the tube and adapted to be partlyprojected through the slots. The springs have their inner ends securedto the tube. An adjustable member is secured to the outer ends of thesprings. Elastic covers extend around that portion of the springsprojecting through the slots.

-   (2) U.S. Pat. No. 797,676 to Flowers.

U.S. Pat. No. 797,676 issued to Flowers on Aug. 22, 1905 teaches asyringe including a nozzle having outlets and an expandable sackenveloping the nozzle, having outlets, and formed with longitudinal ribsstiffening and reinforcing the sack in the direction of its length andadmitting of its diametrical expansion.

-   (3) U.S. Pat. No. 4,416,267 to Garren et al.

U.S. Pat. No. 4,416,267 issued to Garren et al. on Nov. 22, 1983 inclass 128 and subclass 1 R teaches a stomach insert for treating obesityin humans by reducing the stomach volume, which includes a flexibletorus-shaped inflatable balloon having a central opening extendingtherethrough. At least a portion of the balloon has a self-sealingsubstance to facilitate puncture thereof with a needle for inflating theballoon and sealing of the puncture upon removal of the needle. Themethod includes positioning the balloon inside the stomach of the personbeing treated for obesity so as to reduce the stomach volume.

-   (4) U.S. Pat. No. 4,694,827 to Weiner et al.

U.S. Pat. No. 4,694,827 issued to Weiner et al. on Sep. 22, 1987 inclass 128 and subclass 303 R teaches generally, a balloon insertable andinflatable in the stomach to deter ingestion of food and having, wheninflated, a plurality of smooth-surfaced convex protrusions disposed topermit engagement of the stomach wall by the balloon only at spacedlocalities for minimizing mechanical trauma of the stomach wall by theballoon.

Specifically, as shown in FIG. 1, which is a diagrammatic sideelevational view in partial section of a prior art balloon fullyexpanded within a stomach, a balloon 10 being flexible-walled,imperforate, air-inflatable, and insertable and inflatable within thestomach 12 of a human 14 or animal 16 to deter ingestion of food 18 byoccupying a substantial portion 20 of the volume 22 of the stomach 12 istaught. The balloon 10 has a plurality of wall portions 24 formingprotrusions 26 that are smooth-surfaced, convex, and outward wheninflated. The protrusions 26 are distributed around the balloon 10 andcooperatively define a plurality of channels 28 that are outwardly openfor passage of fluent material 30 between the outer surface 32 of theballoon 10 and the wall 34 of the stomach 12, and are shaped anddisposed to permit engagement of the wall 34 of the stomach 12 by theballoon 10 only at spaced localities 36 so as to maintain a substantialportion 38 of the wall 34 of the stomach 12 away from contact with theballoon 10 for minimizing complications due to mechanical trauma of theballoon 10 against the wall 34 of the stomach 12.

The protrusions 26 and the channels 28 minimize physical contact withthe wall 34 of the stomach 12 and stimulate cytoprotection.Cytoprotection is an innate mechanism of preservation of the stomach 12from adverse effects of a harsh environment of a gastric lumen.

It is apparent that numerous innovations for inflatable medical deviceshave been provided in the prior art that are adapted to be used.Furthermore, even though these innovations may be suitable for thespecific individual purposes to which they address, however, they wouldnot be suitable for the purposes of the embodiments of the presentinvention as heretofore described, namely, a multi-method andmulti-apparatus for treating obesity.

SUMMARY

Thus, an object of the embodiments of the present invention is toprovide a multi-method and multi-apparatus for treating obesity, whichavoids the disadvantages of the prior art.

Briefly stated, another object of the embodiments of the presentinvention is to provide a multi-method and multi-apparatus for treatingobesity. The multi-method includes a method for estimating a volume ofan intragastric balloon appropriate for an individual patient, a methodfor using an enterocutaneous fistula to inspect an intragastric balloonwithout sedation and endoscopic complications associated with an upperendoscopy, and a method for decreasing ability of the stomach of anindividual patient to distend or expand after a meal to increase satietyand help the individual patient to comply with a weight less diet. Themulti-apparatus includes an intragastric balloon for inflating withoutinstallation of a pressurized gas or liquid, an intragastric balloon forminimizing trauma of the intragastric balloon on the gastric mucosa, andan intragastric balloon for administering therapeutic medications.

The novel features considered characteristic of the embodiments of thepresent invention are set forth in the appended claims. The embodimentsof the present invention themselves, however, both as to theirconstruction and their method of operation together with additionalobjects and advantages thereof will be best understood from thefollowing description of the specific embodiments when read andunderstood in connection with the accompanying drawing.

BRIEF DESCRIPTION OF THE DRAWINGS

So the manner in which the above recited features of the presentdisclosure can be understood in detail, a more particular description ofembodiments of the present disclosure, briefly summarized above, may behad by reference to embodiments, which are illustrated in the appendeddrawings. It is to be noted, however, the appended drawings illustrateonly typical embodiments of embodiments encompassed within the scope ofthe present disclosure, and, therefore, are not to be consideredlimiting, for the present disclosure may admit to other equallyeffective embodiments, wherein:

FIG. 1 is a diagrammatic side elevational view in partial section of aprior art balloon fully expanded within a stomach;

FIGS. 2A-2C are a flowchart of the method of an embodiment of thepresent invention for estimating volume of an intragastric balloonappropriate for an individual patient;

FIG. 3 is a diagrammatic side elevational view in partial section of aballoon of an embodiment of the present invention fully expanded withina stomach;

FIG. 4 is a diagrammatic side elevational view in partial section of aballoon of another embodiment of the present invention fully expandedwithin a stomach;

FIG. 5 is a diagrammatic side elevational view in partial section of aballoon of another embodiment of the present invention fully expandedwithin a stomach;

FIG. 6 is a diagrammatic side elevational view in partial section of aballoon of another embodiment of the present invention fully expandedwithin a stomach;

FIG. 7 is a diagrammatic side elevational view in partial section of aballoon of another embodiment of the present invention fully expandedwithin a stomach;

FIG. 8 is a diagrammatic side elevational view in partial section of aballoon of another embodiment of the present invention fully expandedwithin a stomach;

FIG. 9 is a diagrammatic side elevational view in partial section of aballoon of another embodiment of the present invention fully expandedwithin a stomach;

FIG. 10A-10B are a flowchart of the method of another embodiment of thepresent invention for using an enterocutaneous fistula to inspect anintragastric balloon without sedation and endoscopic complicationsassociated with an upper endoscopy; and

FIGS. 11A-11E are a flowchart of the method of another embodiment of thepresent invention for decreasing ability of the stomach of an individualpatient to distend or expand after a meal increasing satiety and helpingthe individual patient to comply with a weight loss diet.

The headings used herein are for organizational purposes only and arenot meant to be used to limit the scope of the description or theclaims. As used throughout this application, the word “may” is used in apermissive sense (i.e., meaning having the potential to), rather thanthe mandatory sense (i.e., meaning must). Similarly, the words“include”, “including”, and “includes” mean including but not limitedto. To facilitate understanding, like reference numerals have been used,where possible, to designate like elements common to the figures.

LIST OF REFERENCE NUMERALS UTILIZED IN THE DRAWING A. Prior Art

10 balloon

12 stomach of human 14 or animal 16

14 human

16 animal

18 food

20 substantial portion of volume 22 of stomach 12

22 volume of stomach 12

24 plurality of wall portions

26 protrusions

28 plurality of channels

30 fluent material

32 outer surface of balloon 10

34 wall of stomach 12

36 spaced localities

38 substantial portion of wall 34 of stomach 12

B. Method of Embodiment of Present Invention for Estimating Volume ofIntragastric Balloon Appropriate for Individual Patient

40 method of embodiment of present invention for estimating volume 42 ofintragastric balloon 44 appropriate for individual patient 46

42 volume of intragastric balloon 44 appropriate for individual patient46

44 intragastric balloon appropriate for individual patient 46

46 individual patient

48 water of material 62 ingested

50 physician administering method 40

52 person administering method 40

54 specialized equipment

56 electrogastrograph of specialized equipment 54

58 upper endoscope of specialized equipment 54

60 barostat balloon of specialized equipment 54

62 material ingested

64 water solution suspension of material 62 ingested

66 non-aqueous based material of material 62 ingested

68 temperature

70 room temperature of temperature 68

72 other temperature of temperature 68

74 10 minutes time

76 other interval of time

C. Intragastric Balloon for Inflating without Installation ofPressurized Gas or Liquid

78 intragastric balloon

80 plurality of struts

82 skeleton of intragastric balloon 78

84 protrusions of intragastric balloon 78

86 channels of intragastric balloon 78

90 shape

92 volume of intragastric balloon 78

100 valve of intragastric balloon 78

102 opening of intragastric balloon 78

106 gastric environment

108 holes of plurality of struts 80

110 fastening points of plurality of struts 80

112 internal wires

114 central longitudinal strut of plurality of struts 80

118 one end of central longitudinal strut 114 of plurality of struts 80

120 portion of central longitudinal strut 114 of plurality of struts 80

122 endoscopic device

124 endoscopic forceps

126 stomach

132 grasping point

134 two parallel layers of metals of plurality of struts 80

136 esophagus

138 spring

D. Intragastric Balloon for Minimizing Trauma of Intragastric Balloon onGastric

Mucosa

140 plurality of protrusions

142 balloon

144 one of plurality of protrusions 140

145 opposite side of balloon 142

146 another one of plurality of protrusions 140

148 antral wall of stomach 152

150 proximal portion of stomach 152

152 stomach

154 distal antrum of stomach 152

156 one tether

158 long axis of central longitudinal strut 160 of plurality of struts162

160 central longitudinal strut 160 of plurality of struts 162

162 plurality of struts

164 ball and socket assembly

168 electrical device

169 electrical signals of electrical device 168

170 antrum of stomach 152

172 counterweight

174 fixed counterweight of counterweight 172

176 plurality of struts of balloon 142

E. Intragastric Balloon for Administering Therapeutic Medications

178 therapeutic medication

180 matrix of therapeutic medication 178

182 balloon

184 one of struts 186 of balloon 182

186 struts of balloon 182

190 pocket

192 attachment in wall 194 of balloon 188

196 holes of balloon 182

198 gastric contents

F. Method for Using Enterocutaneous Fistula to Inspect IntragastricBalloon without Sedation and Endoscopic Complications Associated withUpper Endoscopy

200 method of embodiment of present invention for using enterocutaneousfistula 202 to inspect intragastric balloon 204 without sedation andendoscopic complications associated with upper endoscopy

202 enterocutaneous fistula

204 intragastric balloon

206 percutaneous gastrostomy

208 tract

210 upper endoscope

212 stomach

214 gastric mucosa

G. Method for Restricting Expansion of Stomach for Individual Patient

218 method of embodiment of present invention for decreasing ability ofstomach 220 of individual patient 222 to distend or expand after meal224 increasing satiety and helping individual patient 222 to comply withweight loss diet 226

220 stomach of individual patient 222

222 individual patient

224 meal

226 weight less diet

228 balloon

230 other space occupying device

232 pillow

234 band

236 width of band 234

238 weight of individual patient 222

240 anatomy of individual patient 222

242 portion of band 234

244 pressure pack

246 balloon

248 adhesive

250 skin of individual patient 222

252 standard tee shirt

254 other shirt

256 separate tube

258 roentgenography

260 fluoroscopy

262 xiphoid process of sternum 264 of individual patient 222

264 sternum of individual patient 222

266 lower edge of rib cage 268 of individual patient 222

268 rib cage of individual patient 222

270 circumference of portion 272 of stomach 220 of individual patient222

272 portion of stomach 220 of individual patient 222

274 greatest diameter

276 buttons

278 hook and loop fasteners

280 pulley device

282 one end of band 234

284 left upper quadrant portion of stomach 220 of individual patient 222

286 pulse oximetry

288 blood gas measurement

290 capnography

292 tension of band 234

DETAILED DESCRIPTION A. A Method for Estimating Volume of anIntragastric Balloon Appropriate for an Individual Patient

Referring now to the figures, in which like numerals indicate likeparts, and particularly to FIGS. 2A-2C, which are a flowchart of themethod of an embodiment of the present invention for estimating volumeof an intragastric balloon appropriate for an individual patient, themethod of an embodiment of the present invention is shown generally at40 for estimating volume 42 of an intragastric balloon 44 appropriatefor an individual patient 46, and comprises the steps of:

STEP 1: Drinking by the individual patient 46 who is a candidate for theintragastric balloon 44 as much water 48 as possible over a 10 minuteperiod of time.

STEP 2: Monitoring volume of the water 48 ingested.

STEP 3: Advising by the individual patient 46 to a physician 50 orperson 52 administering the method 40 when the individual patient 46feels uncomfortably bloated or alternatively, if the individual patient46 vomits, the volume of the water 48 ingested will be determined.

STEP 4: Selecting for the individual patient 46 the intragastric balloon44 that is a fraction of the volume leading to uncomfortable symptoms,with the volume of the intragastric balloon 44 being 75% of the ingestedvolume of water 48.

STEP 5: Monitoring the individual patient 46 with specialized equipment54 during ingestion, as with, but not limited to, an electrogastrograph56, an upper endoscope 58, or a barostat balloon 60.

STEP 6: Challenging over time, the individual patient 46 with theintragastric balloon 44 with another load of water 48 as in STEP 1 aboveto see if the individual patient 46 can tolerate a larger intragastricballoon 44 because it is anticipated that a larger intragastric balloon44 might be expected to have a greater therapeutic effect in themanagement of obesity and satiety symptoms.

In the above embodiment, the water 48 is specified as material 62ingested. The water 48 is only mentioned as a preferred example. Thematerial 62 ingested may be a water solution suspension 64, or othernon-aqueous based material 66. Temperature 68 is implied as roomtemperature 70, but may be some other temperature 72. Time 74 isspecified as 10 minutes, but may be some other interval of time 76.

B. An Intragastric Balloon for Inflating without Installation of aPressurized Gas or Liquid

As shown in FIG. 3, which is a diagrammatic side elevational view inpartial section of a balloon of an embodiment of the present inventionfully expanded within a stomach, an intragastric balloon 78 comprises aplurality of struts 80. The plurality of struts 80 form a skeleton 82 ofthe intragastric balloon 78, run longitudinally, are parallel toprotrusions 84 and channels 86 of the intragastric balloon 78, arefabricated out of a metal or a composite with a memory for its shape 90,such as nitinol, and are shaped so that when released, they expand tofill out volume 92 of the intragastric balloon 78, with this shape beingthe shape that would otherwise be created if the intragastric balloon 78was inflated with air, water, or both.

The intragastric balloon 78 further comprises a valve 100 or opening 102to allow air and gastric fluid into the intragastric balloon 78 as theintragastric balloon 78 is expanded in the gastric environment 106.

In one embodiment, the plurality of struts 80 have holes 108 or otherfastening points 110 midway. These fastening points 110 are connected byinternal wires 112 to a central longitudinal strut 114 of the pluralityof struts 80 running straight and longitudinally through the length ofthe balloon 78. One end 118 or portion 120 of this central longitudinalstrut 114 of the plurality of struts 80 is accessible by an endoscopicdevice 122.

In another embodiment, with the balloon 78 held steadily in positionwith an endoscopic forceps 124 or an Ewald tube, an instrument can graspthe end 118 of the central longitudinal strut 114 of the plurality ofstruts 80 and pull it. This would collapse the balloon 78, allowing itto be removed from the stomach 126 in its collapsed state.

In another embodiment, there is a shelf or ledge that allows the balloon78 to be stabilized against a standard 36 French Ewald tube tofacilitate traction on the central longitudinal strut 114 of theplurality of struts 80.

In another embodiment, there would be a grasping point 132 for theendoscopic forceps 124 to grasp and stabilize the balloon 78 for removalfrom the stomach 126.

In another embodiment, the plurality of struts 80 obtain their curvedshapes by being configured of two parallel layers of metals 134 withdifferent coefficients of thermal expansion. In this embodiment, theballoon 78 is chilled with ice before its deployment though theesophagus 136 into the stomach 126. At body temperature, the pluralityof struts 80 expand to their designed shapes. On removal, the stomach126 is lavaged with ice water to allow the plurality of struts 80 of theballoon 78 to shrink.

In another embodiment, the central longitudinal strut 114 of theplurality of struts 80 is a spring 138. The spring 138 is stretched whenthe balloon 78 is collapsed and ready to deploy in the stomach 126. Whenreleased in the stomach 126, the spring 138 retracts to itsnon-stretched length, expanding the balloon 78. The spring 138 gives theballoon 78 more resilience, almost like a shock absorber, in the gastricenvironment 106.

C. An Intragastric Balloon for Minimizing Trauma of the IntragastricBalloon on the Gastric Mucosa

As shown in FIG. 4, which is a diagrammatic side elevational view inpartial section of a balloon of another embodiment of the presentinvention fully expanded within a stomach, the plurality of protrusions140 of the balloon 142 run diagonally rather than longitudinally.

As shown in FIG. 5, which is a diagrammatic side elevational view inpartial section of a balloon of another embodiment of the presentinvention fully expanded within a stomach, in another embodiment, one144 of the plurality of protrusions 140 is made more prominent. On anopposite side 145 of the balloon 142, another one 146 of the pluralityof protrusions 140 is made less prominent. When a gastric peristalticwave passes over the balloon 142, more pressure is placed on the one 144of the plurality of protrusions 140 that is more prominent and less onthe one 146 of the plurality of protrusions 140 that is less prominent.As the balloon 142 impacts the antral wall 148 distally, there is atendency for the balloon 142 to rotate along its long axis, which isrepeated with every peristaltic wave, so that different points arepresented to the gastric mucosa.

As shown in FIG. 6, which is a diagrammatic side elevational view inpartial section of a balloon of another embodiment of the presentinvention fully expanded within a stomach, in another embodiment, theballoon 142 is tethered by at least one tether 156 to a proximal portion150 of the stomach 152 to prevent forward migration of the balloon 142to impact in the distal antrum 154. With the one tether 156 attached tolong axis 158 of the central longitudinal strut 160 of the plurality ofstruts 162, the balloon 142 is able to rotate freely with a ball andsocket assembly 164. With the at least one tether 156 attached to theballoon 142, the balloon 142 twists on the at least one tether 156 andthen is forced to turn backwards due to tension on the at least onetether 156. The at least one tether 156 is attached to the balloon 142and the proximal portion 150 of the stomach 152 to maximize stimulationof this area to maximize effects of ghrelin or other digestive hormonesassociated with the stomach 152.

As shown in FIG. 7, which is a diagrammatic side elevational view inpartial section of a balloon of another embodiment of the presentinvention fully expanded within a stomach, in another embodiment, anelectrical device 168 is incorporated into the balloon 142 to provideelectrical signals 169 to the antrum 170 of the stomach 152 to maximizestimulating effects of ghrelin and other digestive hormones.

As shown in FIG. 8, which is a diagrammatic side elevational view inpartial section of a balloon of another embodiment of the presentinvention fully expanded within a stomach, in another embodiment, acounterweight 172 is built into the balloon 142 to accentuateeccentricity of the balloon 142 and allow it to spin. This can be afixed counterweight 174 or attached to the plurality of struts 176 ofthe balloon 142.

D. An Intragastric Balloon for Administering Therapeutic Medications

As shown in FIG. 9, which is a diagrammatic side elevational view inpartial section of a balloon of another embodiment of the presentinvention fully expanded within a stomach, a therapeutic medication 178is placed in a matrix 180 that is slowly dissolving and inert. Thismatrix 180 is deployed loosely in the balloon 182 or fabricated toattach to one 184 of the struts 186 of the balloon 182 or inside apocket 190 or attachment 192 in the wall 194 of the balloon 182.

The balloon 182 is fabricated with holes 196 to freely allow the gastriccontents 198 to enter the balloon 182. The matrix 180 slowly dissolves,thereby releasing the therapeutic medication 178.

E. A Method for Using an Enterocutaneous Fistula to Inspect anIntragastric Balloon without Sedation and Endoscopic ComplicationsAssociated with Upper Endoscopy

As shown in FIGS. 10A-10B, which are a flowchart of the method ofanother embodiment of the present invention for using an enterocutaneousfistula to inspect an intragastric balloon without sedation andendoscopic complications associated with an upper endoscopy, the methodof the embodiment of the present invention is shown generally at 200 forusing an enterocutaneous fistula 202 to inspect an intragastric balloon204 without sedation and endoscopic complications associated with anupper endoscopy, and comprises the steps of:

STEP 1: Placing a percutaneous gastrostomy 206 in a usual manner.

STEP 2: Allowing the percutaneous gastrostomy 206 to heal.

STEP 3: Dilating the tract 208 to allow passage of an upper endoscope210 directly into the stomach 212.

STEP 4: Evaluating the balloon 204 and the gastric mucosa 214.

F. A Method for Restricting Expansion of the Stomach for an IndividualPatient

As shown in FIGS. 11A-11E, which are a flowchart of the method ofanother embodiments of the present invention for restricting expansionof the stomach for an individual patient, the method of the embodimentof the present invention is shown generally at 218 for decreasingability of the stomach 220 of an individual patient 222 to distend orexpand after a meal 224 increasing satiety and helping the individualpatient 222 to comply with a weight loss diet 226, and comprises thesteps of:

STEP 1: Attaching a balloon 228 or other space occupying device 230 orpillow 232 to a band 234 that is of cloth, is 3 inches wide, is one ofresistant to stretching and elastic, has a width 236 that is dependentupon the weight 238 of the individual patient 222 and anatomy 240 of theindividual patient 222, and has a portion 242 thereof widened comparedto the rest of the band 234 to accommodate one of a pressure pack 244and a balloon 246.

STEP 2: Utilizing an adhesive 248 on at least one of the skin 250 of theindividual patient 222 and the band 234 to prevent the band 234 frommigrating while being worn by the individual patient 222.

STEP 3: Utilizing one of a standard tee shirt 252 and other shirt 254having a separate tube 256 within or outside of it allowing the band 234and/or the space-occupying device 230 to be enclosed so that it will becovered or disguised by the separate tube 256.

STEP 4: Utilizing roentgenography 258 or fluoroscopy 260 to locate thestomach 220 of the individual patient 222 to facilitate proper placementof the band 234 and the space-occupying device 230.

STEP 5: Wrapping the band 234 around the stomach 220 of the individualpatient 222 in one of an area caudal to the xiphoid process 262 of thesternum 264 and cranial to the lower edge 266 of the rib cage 268 of theindividual patient 222 and along the circumference 270 of the portion272 of the stomach 220 of the individual patient 222 with the greatestdiameter 274 and in a repeating FIG. 8 so that different areas of theskin 250 of the individual patient 222 are touched by the band 234allowing adjacent areas to recover from tension of the band 234.

STEP 6: Closing/attaching the band 234 with one of buttons 276 and hookand loop fasteners (VELCRO®) 278.

STEP 7: Attaching a pulley device 280 to one end 282 of the band 234 foruse in tightening the band 234.

STEP 8: Applying pressure to the left upper quadrant portion 284 of thestomach 220 of the individual patient 222 by use of one of the balloon228, the other space-occupying device 230, and the pillow 232.

STEP 9: Utilizing one of pulse oximetry 286, blood gas measurement 288,and capnography 290 to determine if the band 234 significantly decreasesrespiratory status of the individual patient 222.

STEP 10: Measuring tension 292 of the band 234 and tension applied tothe skin 250 of the individual patient 222 to ascertain likelihood ofcausing damage or ulceration to the skin 250 of the individual patient222.

In another embodiment, outside appearance of the shirt 254 appearsnormal to an observer, with the band 234 held in place by the cloth tube256. The cloth tube 256 is of such a volume that when the band 234 isactivated, there would be sufficient space to allow the shirt 254 tohang freely.

In another embodiment, the band 234 is incorporated into the tee shirt252 in such a way that it is obvious to a casual observer creating anobvious constriction.

In another embodiment, a device with the appearance of standardsuspenders is attached to an adjustable belt around the waist of theindividual patient 222 to hold the band 234 in a proper position as withone of hook and loop fasteners (Velcro), buttons, and snap devices.

G. The Conclusions

It will be understood that each of the elements described above or twoor more together may also find a useful application in other types ofconstructions differing from the types described above.

While the embodiments of the present invention have been illustrated anddescribed as embodied in a multi-method and multi-apparatus for treatingobesity, however, they are not limited to the details shown, since itwill be understood that various omissions, modifications, substitutions,and changes in the forms and details of the embodiments of the presentinvention illustrated and their operation can be made by those skilledin the art without departing in any way from the spirit of theembodiments of the present invention.

Without further analysis the foregoing will so fully reveal the gist ofthe embodiments of the present invention that others can by applyingcurrent knowledge readily adapt them for various applications withoutomitting features that from the standpoint of prior art fairlyconstitute characteristics of the generic or specific aspects of theembodiments of the present invention.

It should be emphasized that the above-described embodiments of thepresent disclosure are merely possible examples of implementations,merely set forth for a clear understanding of the principles of thedisclosure. Many variations and modifications may be made to theabove-described embodiment(s) of the disclosure without departingsubstantially from the spirit and principles of the disclosure. All suchmodifications and variations are intended to be included herein withinthe scope of this disclosure and the present disclosure and protected bythe following claims.

While the foregoing is directed to embodiments of the present invention,other and further embodiments of the invention may be devised withoutdeparting from the basic scope thereof. For example, although numerousembodiments having various features have been described herein,combinations of such various features in other combinations notdiscussed herein are contemplated within the scope of embodiments of thepresent invention.

What is claimed is:
 1. A method for estimating volume of an intragastricballoon appropriate for an individual patient, the method comprising:drinking by the individual patient, who is a candidate for theintragastric balloon, as much of a fluid as possible over a given periodof time; monitoring volume of the fluid ingested; advising, by theindividual patient, to a physician or person administering the methodwhen the individual patient feels uncomfortably bloated or if theindividual patient vomits so that the volume of the fluid ingested isdetermined; selecting for the individual patient the intragastricballoon that is a fraction of the volume leading to uncomfortablesymptoms; and monitoring the individual patient with specializedequipment during ingestion.
 2. The method of claim 1, wherein thedrinking step includes drinking by the individual patient, who is acandidate for the intragastric balloon, as much fluid as possible over a10 minute period of time.
 3. The method of claim 1, wherein theselecting step includes selecting for the individual patient theintragastric balloon that is 75% of the ingested volume of fluid.
 4. Themethod of claim 1, wherein the monitoring step includes monitoring theindividual patient with one of an electrogastrograph, an upperendoscope, and a barostat balloon.
 5. The method of claim 1, furthercomprising the step of challenging over time the individual patient withthe intragastric balloon with another load of the fluid to see if theindividual patient can tolerate a larger intragastric balloon because alarger intragastric balloon has greater therapeutic effect in managementof obesity and satiety symptoms.
 6. The method of claim 1, wherein thedrinking step includes drinking by the individual patient, who is acandidate for the intragastric balloon, as much of a fluid that isselected from the group consisting of water, a water solution suspensionand a non-aqueous based material as possible over a given period oftime.
 7. The method of claim 1, wherein the selecting step includesselecting for the individual patient the intragastric balloon that willbe a fraction of the volume leading to uncomfortable symptoms at roomtemperature.
 8. A method for using an enterocutaneous fistula to inspectan intragastric balloon without sedation and endoscopic complicationsassociated with an upper endoscopy, comprising: placing a percutaneousgastrostomy in a usual manner; allowing the percutaneous gastrostomy toheal; dilating the tract to allow passage of an upper endoscope directlyinto the stomach; and evaluating the balloon and the gastric mucosa. 9.A method for decreasing ability of the stomach of an individual patientto distend or expand after a meal to increase satiety and help theindividual patient to comply with a weight loss diet, comprising:locating the stomach of the individual patient to facilitate properplacement of a band; wrapping the band around the stomach of theindividual patient; and closing/attaching the band to apply pressure tothe stomach of the individual patient, thereby decreasing the ability ofthe stomach of the individual patient to distend or expand after themeal, thereby increasing the satiety and helping the individual patientto comply with the weight loss diet.
 10. The method of claim 9, whereinthe locating step includes locating the stomach of the individualpatient to facilitate proper placement of a band by utilizing one ofroentgenography and fluoroscopy.
 11. The method of claim 9, wherein thewrapping step includes wrapping the band around the stomach of theindividual patient in one of an area caudal to the xiphoid process ofthe sternum and cranial to the lower edge of the rib cage of theindividual patient and along the circumference of the portion of thestomach of the individual patient.
 12. The method of claim 9, whereinthe closing/attaching step includes closing/attaching the band with oneof buttons and hook and loop fasteners.
 13. The method of claim 9,further comprising the step of attaching a pulley device to one end ofthe band to tighten the band.
 14. The method of claim 9, wherein theclosing/attaching step includes closing/attaching the band to applypressure to the stomach of the individual patient at the left upperquadrant portion of the stomach of the individual patient by use of oneof the balloon, other space-occupying device, and the pillow.
 15. Themethod of claim 9, further comprising the step of utilizing one of pulseoximetry, blood gas measurement, and capnography to determine if theband significantly decreases respiratory status of the individualpatient.
 16. The method of claim 9, further comprising the step ofmeasuring tension of the band and tension applied to skin of theindividual patient to ascertain likelihood of causing damage orulceration to the skin of the individual patient.
 17. The method ofclaim 9, further comprising the step of attaching one of a balloon,another space occupying device, and a pillow to the band.
 18. The methodof claim 17, wherein the locating step includes locating the stomach ofthe individual patient to facilitate proper placement of a band that isof cloth, is 3 inches wide, is one of resistant to stretching andelastic, has a width that is dependent upon weight of the individualpatient and anatomy of the individual patient, and has a portion thereofwidened compared to the rest of the band to accommodate one of theballoon, the another space occupying device, and the pillow.
 19. Themethod of claim 9, further comprising the step of utilizing an adhesiveon at least one of the skin of the individual patient and the band toprevent the band from migrating while being worn by the individualpatient.
 20. The method of claim 9, further comprising the step ofattaching a device with an appearance of standard suspenders to anadjustable belt around the waist of the individual patient to hold theband in a proper position by one of hook and loop fasteners, buttons,and snap devices.